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Efficacy of Hypoallergenic diet and administration of Ranitidine in treatment of Gastroesophageal reflux disease in infants one month to one years old

Protocol summary

Summary
The purpose of this study is to compare the effects of a hypoallergenic diet, and ranitidine administration in treating infants (1-12 months) with gastroesophageal reflux. Infants with vomiting or those with regurgitation plus one of the following symptoms: irritability, insufficient weight gain and respiratory distress will be enrolled in this study. Anyone with obstructive diseases, kidney diseases, central nervous system diseases (CNS), severe respiratory symptoms such as cyanosis, apnea, or respiratory distress will be excluded from the study. Patients are selected from infants who are referred to the Isfahan University of Medical Sciences Clinics. A sample size of 50 was calculated and patients will be randomly allocated in two groups to receive ranitidine or follow a hypoallergenic diet. For two weeks, those in the ranitidine group will receive 10 mg/kg of ranitidine daily divided into 2 doses, and in the diet group, all allergens are eliminated from the mother’s diet. At the end of the two weeks, frequency and volume of vomiting, irritability, weight gain, respiratory symptoms and arching will be compared before and after intervention between the two groups.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015042714882N3
Registration date: 2016-02-16, 1394/11/27
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2016-02-16, 1394/11/27
Registrant information
Name
Fatemeh Famouri
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3663 7291
Email address
famouri@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Isfahan University of Medical Science
Expected recruitment start date
2014-04-21, 1393/02/01
Expected recruitment end date
2015-01-30, 1393/11/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
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Scientific title
Efficacy of Hypoallergenic diet and administration of Ranitidine in treatment of Gastroesophageal reflux disease in infants one month to one years old
Public title
Efficacy of Hypoallergenic diet on infant's reflux
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:1 month to 1 year infants with vomiting or regurgitation plus one of following symptoms, Irritability; Insufficient weight gain; Respiratory symptoms. Exclusion criteria: Renal disease; urinary tract infection(UTI); CNS (Central nerves system); Respiratory symptoms; Apnea; Cyanosis; Respiratory distress.
Age
From 1 month old to 1 year old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 50
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Randomization of patients into two treatment groups will be done using lottery cards. Twenty-five pairs of cards, each of which has a letter A or B (based on its designated treatment method) are placed inside a container, and the patients’ parents are requested to take a card from that container. Based on the card’s letter, each patient will be assigned to one of the treatment groups. This process continues until all patients are assigned to a group.

Secondary Ids

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Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Isfahan University of Medical Sciences
Street address
Isfahan, Isfahan University of Medical Sciences
City
Isfahan
Postal code
81746-73461
Approval date
2014-08-27, 1393/06/05
Ethics committee reference number
393605

Health conditions studied

1

Description of health condition studied
Gastroesophaseal reflux
ICD-10 code
K21.9
ICD-10 code description
Gastro-oesophageal reflux disease without oesophagitis(Oesophageal reflux NOS)

Primary outcomes

1

Description
Frequency of vomiting per day
Timepoint
Two weeks after intervention
Method of measurement
Counting the episode of vomiting per day. Asking question from mothers and recording in questionnaire

2

Description
Volume of vomiting
Timepoint
Two weeks after intervention
Method of measurement
Asking question from mother about volume of vomiting and recording in questionnaire

Secondary outcomes

1

Description
Irritability severity
Timepoint
Two weeks after intervention
Method of measurement
Asking question from mothers and recording in questionnaire

2

Description
Weight gain
Timepoint
Two weeks after intervention
Method of measurement
Weighing patient

3

Description
Respiratory symptoms
Timepoint
Two weeks after intervention
Method of measurement
Asking question from mothers and recording in questionnaire

4

Description
Arching
Timepoint
Two weeks after intervention
Method of measurement
Asking question from mothers and recording in questionnaire

Intervention groups

1

Description
The treatment group will be eliminate allergens from mother's diet for 2 weeks. Hypoallergenic diet was defined, diet free of milk and dairy products, cow’s meat, peanut, fish and soy.
Category
Lifestyle

2

Description
The Ranitidine consumer group will receive Ranitidine 10 mg per kg per day divided to 2 doses for 2 week. (Ranitidine syrup 15 mg per ml, Alhavi Pharmaceutical Company)
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Emam Hossein(A) Hospital
Full name of responsible person
Dr. Fatemeh Famouri
Street address
Emam Hossein(A) Hospital, Isfahan, Iran
City
Isfahan

2

Recruitment center
Name of recruitment center
Out Patient Academic Clinic of Isfahan University of Medical Sciences
Full name of responsible person
Dr. Fatemeh Famouri
Street address
Sepahsalar Street, Isfahan
City
Isfahan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Isfahan University of Medical Sciences
Full name of responsible person
Dr Mansour Siavash
Street address
Isfahan University of Medical Sciences, Isfahan, Iran
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Isfahan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Child Growth and Development Center and Pediatric Group of Isfahan University of Medical Sciences
Full name of responsible person
Dr. Nazanin Zibanejad
Position
Pediatric Resident
Other areas of specialty/work
Street address
Imam Hossein(A) Hospital, Isfahan, Iran
City
Isfahan
Postal code
81746-73461
Phone
+98 31 3386 6266
Fax
+98 31 3386 8286
Email
famouri@med.mui.ac.ir
Web page address
www.mui.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Child Growth and Development Center and Pediatric Group of Isfahan University of Medical Sciences
Full name of responsible person
Dr. Fatemeh Famouri
Position
Assistant Professor, Gastrointestinal and Hepatology Subspecialist
Other areas of specialty/work
Street address
Imam Hossein(A) Hospital, Isfahan, Iran
City
Isfahan
Postal code
81746-73461
Phone
+98 31 3386 6266
Fax
+98 31 3386 8286
Email
famouri@med.mui.ac.ir
Web page address
www.mui.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Child Growth and Development Center and Pediatric Group of Isfahan University of Medical Sciences
Full name of responsible person
Dr. Roya Kelishadi
Position
Professor/Pediatrician
Other areas of specialty/work
Street address
Imam Hossein(A) Hospital, Isfahan, Iran
City
Isfahan
Postal code
81746-73461
Phone
+98 31 3386 6266
Fax
+98 31 3386 8286
Email
kelishadi@med.mui.ac.ir
Web page address
www.mui.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
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Study Protocol
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Statistical Analysis Plan
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Informed Consent Form
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Clinical Study Report
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Analytic Code
empty
Data Dictionary
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